NDC 0378-3850

Phenytoin

Phenytoin

Phenytoin is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Phenytoin.

Product ID0378-3850_27a1d06e-f2f6-4219-b0e8-2af628ba62f9
NDC0378-3850
Product TypeHuman Prescription Drug
Proprietary NamePhenytoin
Generic NamePhenytoin
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2012-12-26
Marketing End Date2022-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA200691
Labeler NameMylan Pharmaceuticals Inc.
Substance NamePHENYTOIN
Active Ingredient Strength50 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC Exclude FlagN

Packaging

NDC 0378-3850-01

100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0378-3850-01)
Marketing Start Date2012-12-26
Marketing End Date2022-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3850-01 [00378385001]

Phenytoin TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA200691
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-26

NDC 0378-3850-05 [00378385005]

Phenytoin TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA200691
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-26

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN50 mg/1

OpenFDA Data

SPL SET ID:15d32f84-14f6-49a6-9bad-d7f4b14eaf14
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1313885
  • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Cytochrome P450 1A2 Inducers [MoA]
    • Cytochrome P450 2B6 Inducers [MoA]
    • Cytochrome P450 2C8 Inducers [MoA]
    • Cytochrome P450 2C19 Inducers [MoA]
    • Cytochrome P450 2D6 Inducers [MoA]
    • Cytochrome P450 3A Inducers [MoA]
    • Cytochrome P450 2C9 Inducers [MoA]

    NDC Crossover Matching brand name "Phenytoin" or generic name "Phenytoin"

    NDCBrand NameGeneric Name
    0121-0892PhenytoinPhenytoin
    0378-3850PhenytoinPhenytoin
    0615-7764PhenytoinPhenytoin
    0904-7079PhenytoinPhenytoin
    0904-7199PhenytoinPhenytoin
    17856-0067PhenytoinPhenytoin
    17856-4069PhenytoinPhenytoin
    17856-4070PhenytoinPhenytoin
    51079-129PhenytoinPhenytoin
    51672-4069PhenytoinPhenytoin
    51672-4146PhenytoinPhenytoin
    59762-0531PhenytoinPhenytoin
    70518-0841PhenytoinPhenytoin
    70518-1967PhenytoinPhenytoin
    60432-131PhenytoinPhenytoin
    60687-156PhenytoinPhenytoin
    60687-275PhenytoinPhenytoin
    64950-231PhenytoinPhenytoin
    66689-775PhenytoinPhenytoin
    66689-036PhenytoinPhenytoin
    70518-2554PhenytoinPhenytoin
    0071-0007Dilantin InfatabsPhenytoin
    0071-2214Dilantin-125Phenytoin
    0615-8260Phenytoin InfatabsPhenytoin
    0615-8424Phenytoin InfatabsPhenytoin

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